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FDA Approval

Para Grass Pollen

CompanyNelco Laboratories, Inc. (DUNS: 054980867)

Effective Date

December 4, 2009

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Urochloa mutica pollen(0.05 g in 1 mL)

Registrants (1)

Nelco Laboratories, Inc.

DUNS Number

054980867

Manufacturing Establishments (1)

Nelco Laboratories, Inc.

Labeler

Nelco Laboratories, Inc.

Registrant

Nelco Laboratories, Inc.

DUNS Number

054980867

Products (1)

Para Grass Pollen

NDC Product Code

36987-2352

Application Number

BLA102192

Marketing Category

BLA (C73585)

Route of Administration

INTRADERMAL, SUBCUTANEOUS

Effective Date

December 4, 2009

Ingredients

PHENOLInactive

Code: 339NCG44TVClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

Urochloa mutica pollenActive

Code: 3ZO9YGZ8ZJClass: ACTIBQuantity: 0.05 g in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

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